Prodigy Pocket Blood Glucose Monitoring System 050302Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00384840503021), received between Sep 12, 2017 and Jul 16, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  REPORTER ALLEGED THAT ON (B)(6) 2018 AT APPROXIMATELY 1230, MEDICAL ATTENTION WAS SOUGHT DUE TO THE END-USER BEING HYPOGLYCEMIC. REPORTER STATED ON INITIAL CONTACT "MY WIFE HAD AN EXTREME SUGAR LOW YESTERDAY, YESTERDAY MORNING HER SUGAR TESTED USING THIS METER AND TEST STRIPS AT 89. I GAVE HER, HER PRESCRIBED INSULIN DOSAGE AT 830 IN THE MORNING AND ABOUT 1030 SHE WAS NOT FEELING WELL, LAID DOWN TO TAKE A NAP. I WENT TO WAKE HER UP FOR LUNCH AT 1230, I COULDN'T WAKE HER UP, SHE WAS UNCONSCIOUS IN COLD SWEAT. IT LOOKED LIKE SYMPTOMS OF A SUGAR LOW TO ME, I RETESTED HER SUGAR USING THE SAME METER IT READ 72. I CALLED 911 THEY DISPATCHED AN AMBULANCE, THE AMBULANCE TESTED HER SUGAR AT 28. SHE WAS ADMITTED TO THE HOSPITAL, SPENT THE NIGHT IN THE HOSPITAL WITH IVS, THEY GOT HER SUGAR UNDER CONTROL AND SHE'S AT HOME NOW." REPORTER STATED THAT APPROXIMATELY 20-30 MINUTES WERE BETWEEN TESTING THE PRODIGY METER AND THE PARAMEDICS TESTING THE END-USER. REPORTER STATED THE PARAMEDICS GAVE THE END-USER AN "IV GLUCOSE SOLUTION" AND TRANSPORTED END-USER TO THE HOSPITAL. REPORTER IS UNAWARE OF WHAT THE END-USER BLOOD GLUCOSE WAS UPON ARRIVAL AT THE HOSPITAL. REPORTER STATED THAT NO OTHER TREATMEN

  Patient problems: Hypoglycemia; Incontinence; Sweating

  MAUDE report 7689945 ↗
• InjuryOct 6, 2017Low Readings; Low Readings

  IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 10:30 AM AFTER THE END USERS PRODIGY DIABETES METER WAS NOT OPERATING PROPERLY AND HE WAS UNABLE TO OBTAIN AN APPROPRIATE READING. THE END USER EXPERIENCED A LOW BLOOD GLUCOSE SEIZURE ACCOMPANIED WITH A READING OF 62 MG/DL. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 42 MG/DL. THE END USER WAS GIVEN AN IV AND DEXTROSE INJECTION ALONG WITH BEING TRANSPORTED TO THE ER. SIMULTANEOUSLY HE RECEIVED ANOTHER DEXTROSE INJECTION AND IV SALINE. A BLOOD GLUCOSE TEST WAS PERFORMED AS WELL AS EXAMINING HIS POTASSIUM LEVELS. AT THE TIME OF THIS CALL THE END USER WAS CURRENTLY STILL IN THE HOSPITAL AND NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

  Patient problems: Hypoglycemia; Seizures

  MAUDE report 6921374 ↗
• InjurySep 12, 2017Incorrect Or Inadequate Test Results

  IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 10:30 AM AFTER THE END USERS PRODIGY DIABETES METER WAS NOT OPERATING PROPERLY AND HE WAS UNABLE TO OBTAIN AN APPROPRIATE READING. THE END USER EXPERIENCED A LOW BLOOD GLUCOSE SEIZURE ACCOMPANIED WITH A READING OF 62 MG/DL. THE PARAMEDICS WERE CALLED AND UPON ARRIVAL THEY PERFORMED A BLOOD GLUCOSE TEST WITH THEIR METER AND THE RESULT WAS 42 MG/DL. THE END USER WAS GIVEN AN IV AND DEXTROSE INJECTION ALONG WITH BEING TRANSPORTED TO THE ER. SIMULTANEOUSLY HE RECEIVED ANOTHER DEXTROSE INJECTION AND IV SALINE. A BLOOD GLUCOSE TEST WAS PERFORMED AS WELL AS EXAMINING HIS POTASSIUM LEVELS. AT THE TIME OF THIS CALL THE END USER WAS CURRENTLY STILL IN THE HOSPITAL AND NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 6858814 ↗